EP0661065A2 - Système de perfusion avec dispositif de réglage - Google Patents

Système de perfusion avec dispositif de réglage Download PDF

Info

Publication number: EP0661065A2
Authority: EP; European Patent Office
Prior art keywords: semantic; domain; evaluation; variables; fuzzy
Prior art date: 1993-12-29
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Granted

Application number

EP94120253A

Other languages

German (de)

English (en)

Other versions

EP0661065A3 (fr

EP0661065B1 (fr

Inventor

Otfried Prof. Dr. Ing. Röher

Steffen Korth

Roberto Belke

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

B Braun Melsungen AG

Original Assignee

B Braun Melsungen AG

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

1993-12-29

Filing date

1994-12-21

Publication date

1995-07-05

1994-12-21 Application filed by B Braun Melsungen AG filed Critical B Braun Melsungen AG

1995-07-05 Publication of EP0661065A2 publication Critical patent/EP0661065A2/fr

1996-02-07 Publication of EP0661065A3 publication Critical patent/EP0661065A3/fr

1999-07-07 Application granted granted Critical

1999-07-07 Publication of EP0661065B1 publication Critical patent/EP0661065B1/fr

2014-12-21 Anticipated expiration legal-status Critical

Status Expired - Lifetime legal-status Critical Current

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Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
- A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure

Definitions

the invention relates to an infusion system with a control device that automatically adapts the medication dosage to the multifactorial influences of the time-changing patient condition.
the infusion of medication is an indispensable therapeutic measure for maintaining the vital functions of the human organism.
multifactorial influences with high non-linearities are characteristic of the frequently occurring complications .
the mechanisms of action of the individual influencing factors are known qualitatively, but their complex interaction is largely unexplored.
the causal relationships of the complications are thus characterized by a high proportion of fuzzy knowledge.
controllers used are based on a black box model that is valid under stationary or quasi-stationary conditions. Such controllers therefore do not respond, or react only insufficiently, to the spontaneous changes in sensitivity of the body's own regulation system. Other disadvantages arise in processes with longer dead times, such as they usually occur in the human organism when infused with medication.
controller structures with adaptive properties are used.
the adaptation of the infusion rate to the changing patient condition takes place by means of predefined algorithms, some of which also allow a preliminary estimate for the period until the drug begins to take effect.
the algorithms were created on the basis of individual active components of the multifactorial control mechanisms. These regulators therefore only achieve useful results as long as the underlying causal relationships actually determine the current course of action in drug infusion.
infusion systems are therefore required that can capture and evaluate several qualitatively different influencing components as fuzzy knowledge and, taking their semantic significance into account, include them in the automatic regulation of the drug dosage.
the Interactions between the drug dosage and the target values of the treatment such as ultrafiltration rate, total fluid withdrawal, sodium balance and other important control parameters are continuously taken into account.
fuzzy controllers also do not meet the requirements mentioned for the following reasons:
the medical goal of blood pressure control is exclusively to keep the blood pressure constant at the setpoint during the intra- and postoperative phase. Only the blood pressure and variables derived from it, such as the deviation from the target blood pressure value (error) and its change over time (rate), are used as the decision-making features of the fuzzy controller.
the regulation is therefore limited to only one semantic domain. Additional influencing factors from a simultaneous therapy measure are not taken into account.
the object of the invention is therefore to create an infusion system with a control device which has several influencing variables with different physiological mechanisms of action, ie several semantic domains, actively involved in automatic drug dosing as fuzzy knowledge, taking into account the different semantic meaning of the individual domains.
an infusion system with a regulating device for controlling at least one infusion device, which contains several fuzzy controllers in a hierarchical system structure.
the measured variables and / or linguistic variables determined are recorded by a central measured value processing unit and from this further variables are derived which are essential for the evaluation.
the semantic analyzer contains a first fuzzy controller, which links all input variables with their associated fuzzy sets (fuzzyfication) and uses integrated fuzzy logic in each semantic domain to determine the total affiliations for all states defined in the associated rule base.
each individual domain is transferred from the semantic analyzer of the first hierarchy level as a sharp control variable (defuzzification) to the associated further fuzzy controller of the second hierarchy level. Furthermore, each additional fuzzy controller selectively receives all input variables that were determined by the measured value processing unit for its domain.
Each fuzzy controller also has a domain-specific rule base and modules for fuzzy, logical connection, fuzzy inference and defuzzification.
the infusion system according to FIG. 1 has a hierarchically structured control device 10 to which n different measuring devices 11, 12 are connected. Since the infusion system is used to stabilize blood pressure during extracorporeal blood washing, a blood pressure measuring device is used as the measuring device 11, which measures the systolic and / or mean arterial blood pressure of the patient as a measuring quantity M 1.
Measured variables can also be included that affect blood pressure during extracorporeal blood washing via the transmembrane mass transfer, e.g. Ultrafiltrate amount and rate, dialysate composition and temperature, sodium balance and medication consumption.
Linguistic information 13 such as subjective patient complaints, medical comments and additional therapy instructions, are entered as a linguistic variable L 1 ... L m via an input unit 14, preferably a keyboard, into the control device 10.
a first fuzzy controller 17 is used for the semantic analysis.
FIG. 2a shows a schematic representation of the semantic domain hypotension processed in the first fuzzy controller 17.
the domain is divided into the subdomains blood pressure drop (BD drop), hypotension trend and subjective complaints and thus contains 64 (43) different conditions.
the rule base of the fuzzy controller developed on this basis accordingly consists of a status scale with 64 rules.
Each condition is assigned a drug dose D * n in the form of a fuzzy set, determined by the associated rule, in the form of a fuzzy set, as shown in FIG. 4 using the example of two rules D * n and D * n + 1 .
the x-axis represents the entire dose range over which the 64 rules are distributed according to their dose.
the variety of the blood pressure-relevant influencing components is illustrated by the semantic domains plasma volume in FIG. 2b and ultrafiltration in FIG. 2c, whereby in contrast to FIG. 2a the blood pressure itself does not appear as a decision criterion in both domains.
FIG. 3 shows, using the example of the membership functions of three different decision criteria, how the fuzzy sets for unsharp knowledge are stored in the fuzzy controller 17.
the membership functions 25 for the decision criterion blood pressure drop (BD drop) are shown in FIG. 3a.
the relative drop in blood pressure (P0-P) / P0 is plotted along the abscissa, with P0 being the preselected target blood pressure and P the currently measured blood pressure.
the membership values c are plotted along the ordinate on a scale from "0" to "1".
the decision criterion BD drop is assigned four linguistic variables as feature intervals in the form of fuzzy sets, namely the intervals "approx. zero", “low”, “moderate” and “strong". Each of these feature intervals is trapezoidal, the trapezoids can be symmetrical or asymmetrical and overlap one another.
3b shows the membership functions 26 for the hypotension trend criterion.
the four linguistic variables are "negative”, “zero”, “moderately positive” and “strongly positive”.
the fuzzy verification takes place using trapezoidal or triangular membership functions in the value range 0 ... 1.
the current value is denoted by B *.
B * the intersection of B * membership values> 0 with the fuzzy sets "moderately positive” and "strongly positive” result.
the third decision criterion subjective complaints in FIG. 3 c records information about headache, nausea and vomiting, which are entered into the keyboard 14 with an evaluation of their strength level.
the current value C * for this decision criterion marks equal-sized membership values of 0.5 for the characteristic intervals "low” and "moderate”.
the membership functions of Fig. 3c are designated 27.
the first semantic evaluation of the individual domains is determined from this by calculating the center of gravity and the moment of total membership of all activated states of the domain.
the moment of a semantic domain results from the position of the center of gravity of all total affiliations of this domain.
Fig. 4 illustrates the calculation of the center of gravity of a domain and its moment using the example of two activated states D * n and D * n + 1 , where n here is a number from 1 to 64 on the state scale and the number of the state in the relevant one Domain indicates.
Each state 28 is defined by a trapezoidal fuzzy set, the position of which on the x-axis marks its dose range.
the two hatched areas correspond to the total affiliations c tot n and c tot n + 1 , which are determined from the intersections of the current facts A *, B * and C * with the fuzzy sets of the relevant domain.
the center of gravity and the moment of both states are calculated from the size of the hatched areas and their position on the x-axis.
d * is the abscissa value of the center of gravity of the two hatched areas, and the moment is the product of the distance d * from the final value 29 of the state scale and the area of the hatched areas.
the semantic analyzer 16 has a domain evaluation unit 18, the mode of operation of which FIG. 5 illustrates hypotension, plasma volume and ultrafiltration using the semantic domains shown in FIGS. 2a-c.
the domain evaluation unit 18 the medical knowledge about the medical status of the various conditions and the conclusions are stored, which are to be drawn taking into account the determined moments of the individual domains.
each individual domain is weighted using a specified factor.
the domain evaluation unit 18 determines the extent to which the fuzzy controllers of the second hierarchical level are involved in the calculation of the medication quantities or infusion rates to be applied by the connected infusion device 21.
the fuzzy controller 17 After the fuzzy controller 17 has determined the moments of all semantic domains in the first semantic evaluation stage, the total affiliations c ges n of the activated states with regard to their localization with respect to semantically determined fields 30, 31 are determined in the second semantic evaluation stage according to FIG. 32 analyzes that are of primary importance for medical decisions on dosing.
the lines 28 in FIG. 5 correspond to the total affiliations c tot , as are marked in FIG. 4 by the hatched areas of the states 28.
the moment of the domain concerned receives a weighting factor> 1.
the numerical values of these weighting factors can differ depending on the domain. For example, in Fig.
the moment of the hypotension domain is 0.8 and the predetermined weighting factor 2, a weighted moment of 1.6 results.
the weighting factor is set to 1, so that the moment and the weighted moment of this domain are identical.
the domain evaluation unit 18 analyzes whether total memberships c tot n exist which exceed a predetermined maximum value c max and at the same time intersect a hatched field, as outlined in the plasma volume domain in FIG. 5.
This third semantic evaluation level allows weighting factors analogous to the second evaluation level as well as controversial evaluations if a strongly activated condition, as outlined in the plasma volume domain, requires a predominantly or exclusively plasma volume-controlled infusion from a medical point of view.
An exclusively plasma volume-controlled infusion can be achieved, for example, in the third assessment level by using the weighting factor 1 for the domain plasma volume and by canceling the previous weightings for the domains hypotension and ultrafiltration by a weighting factor 0.
the fuzzy controllers 2 to u designated 19 in the second hierarchy level automatically multiply their domain-specific inference results by the value shown in the last (right) table column for the overall semantic evaluation of their domain.
the control variable accumulator 20 summarizes the results of the individual domains and forms the total control variable for the connected infusion device 21. For this purpose, the sum of all semantic evaluations is set equal to 100% and the inference results of the individual fuzzy controllers 2 ... u with the corresponding one Percentage of their domain multiplied. This normalization to 100% ensures that the predetermined maximum dose can never be exceeded even with high dose proportions of the individual domains. The sum of the normalized percentages of all domains directly indicates the amount of medication or infusion rate to be administered by the infusion device 21.

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Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
General Health & Medical Sciences (AREA)
Engineering & Computer Science (AREA)
Anesthesiology (AREA)
Biomedical Technology (AREA)
Heart & Thoracic Surgery (AREA)
Vascular Medicine (AREA)
Hematology (AREA)
Animal Behavior & Ethology (AREA)
Diabetes (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Infusion, Injection, And Reservoir Apparatuses (AREA)
External Artificial Organs (AREA)
Medical Treatment And Welfare Office Work (AREA)
Feedback Control In General (AREA)

EP94120253A 1993-12-29 1994-12-21 Système de perfusion avec dispositif de réglage Expired - Lifetime EP0661065B1 (fr)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
DE4344872		1993-12-29
DE4344872		1993-12-29

Publications (3)

Publication Number	Publication Date
EP0661065A2 true EP0661065A2 (fr)	1995-07-05
EP0661065A3 EP0661065A3 (fr)	1996-02-07
EP0661065B1 EP0661065B1 (fr)	1999-07-07

Family

ID=6506475

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
EP94120253A Expired - Lifetime EP0661065B1 (fr)	1993-12-29	1994-12-21	Système de perfusion avec dispositif de réglage

Country Status (6)

Country	Link
US (1)	US5503624A (fr)
EP (1)	EP0661065B1 (fr)
JP (1)	JPH07255842A (fr)
AT (1)	ATE181844T1 (fr)
DE (1)	DE59408473D1 (fr)
ES (1)	ES2133472T3 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
EP0830179A1 (fr) *	1996-03-29	1998-03-25	Martin Busch	Procede et dispositif pour la production de donnees d'evaluation avantages/risques concernant la radiotherapie de patients
DE19821534C1 (de) *	1998-05-14	1999-08-19	Braun Melsungen Ag	Blutreinigungsmaschine
EP2772275A1 (fr) *	2013-02-28	2014-09-03	B. Braun Avitum AG	Logique floue

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US5927349A (en)	1996-12-09	1999-07-27	Baxter International Inc.	Compounding assembly for nutritional fluids
EP2336922A1 (fr) *	1998-06-26	2011-06-22	STMicroelectronics S.r.l.	Procédé et dispositif correspondant pour la mesure et le traitement de signaux physiques à surveiller, en particulier le signal de pression artérielle au moyen des règles de logique floue
US6199603B1 (en)	1998-08-14	2001-03-13	Baxter International Inc.	Compounding assembly for nutritional fluids
EP1514562B1 (fr) *	1999-04-30	2009-04-22	Children's Hospital Medical Center	Système d'hémofiltration
US6623579B1 (en) *	1999-11-02	2003-09-23	Alien Technology Corporation	Methods and apparatus for fluidic self assembly
US7775986B2 (en) *	2007-04-10	2010-08-17	B. Braun Medizintechnologie Gmbh	Therapy device with a time-variable blood regulation
US8753515B2 (en)	2009-12-05	2014-06-17	Home Dialysis Plus, Ltd.	Dialysis system with ultrafiltration control
US8501009B2 (en)	2010-06-07	2013-08-06	State Of Oregon Acting By And Through The State Board Of Higher Education On Behalf Of Oregon State University	Fluid purification system
CA2851245C (fr)	2011-10-07	2019-11-26	Home Dialysis Plus, Ltd.	Purification de fluide d'echange de chaleur pour un systeme de dialyse
SE537628C2 (sv)	2013-11-08	2015-08-18	Bonvisi Ab	Anordning för irrigation och insufflation med blodtrycksberoende tryckstyrning
JP6657186B2 (ja)	2014-04-29	2020-03-04	アウトセット・メディカル・インコーポレイテッドＯｕｔｓｅｔＭｅｄｉｃａｌ，Ｉｎｃ．	透析システムおよび方法
WO2018035520A1 (fr)	2016-08-19	2018-02-22	Outset Medical, Inc.	Système et procédés de dialyse péritonéale
ES3028957T3 (en)	2018-08-23	2025-06-20	Outset Medical Inc	Dialysis system and methods
CN113795286A (zh)	2019-04-30	2021-12-14	开端医疗公司	透析系统和方法

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
ES2014727A6 (es) *	1989-07-04	1990-07-16	Borches Jacassa Daniel	Perfeccionamientos en los sistemas de administracion de farmacos.

1994
- 1994-12-21 DE DE59408473T patent/DE59408473D1/de not_active Expired - Lifetime
- 1994-12-21 ES ES94120253T patent/ES2133472T3/es not_active Expired - Lifetime
- 1994-12-21 AT AT94120253T patent/ATE181844T1/de active
- 1994-12-21 EP EP94120253A patent/EP0661065B1/fr not_active Expired - Lifetime
- 1994-12-23 US US08/372,811 patent/US5503624A/en not_active Expired - Lifetime
- 1994-12-28 JP JP6327727A patent/JPH07255842A/ja active Pending

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
EP0830179A1 (fr) *	1996-03-29	1998-03-25	Martin Busch	Procede et dispositif pour la production de donnees d'evaluation avantages/risques concernant la radiotherapie de patients
DE19821534C1 (de) *	1998-05-14	1999-08-19	Braun Melsungen Ag	Blutreinigungsmaschine
EP0956872A2 (fr)	1998-05-14	1999-11-17	B. Braun Melsungen Ag	Appareil de purification du sang
EP2772275A1 (fr) *	2013-02-28	2014-09-03	B. Braun Avitum AG	Logique floue
US9486568B2 (en)	2013-02-28	2016-11-08	B. Braun Avitum Ag	Fuzzy logic

Also Published As

Publication number	Publication date
EP0661065A3 (fr)	1996-02-07
ES2133472T3 (es)	1999-09-16
US5503624A (en)	1996-04-02
DE59408473D1 (de)	1999-08-12
EP0661065B1 (fr)	1999-07-07
ATE181844T1 (de)	1999-07-15
JPH07255842A (ja)	1995-10-09

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Publication	Publication Date	Title
EP0661065B1 (fr)	1999-07-07	Système de perfusion avec dispositif de réglage
DE69712371T2 (de)	2002-08-22	Verfahren und Vorrichtung zur Unterstützung eines Benutzers zum Erzeugen eines medizinischen Protokolls
DE69214410T2 (de)	1997-04-30	Verfahren zur ueberwachung eines dialysegeraet
DE60127694T2 (de)	2007-12-27	Dialysegerät und verfahren zum kontrollieren der funktionalität eines dialysegeräts
EP2835143B1 (fr)	2018-12-19	Dispositif de prédiction de paramètres intradialytiques
DE102008002898B4 (de)	2024-02-29	Erkennung von Anomalien bei der Messung des Betäubungsgrades
DE60121749T2 (de)	2007-08-02	System zum adaptiven Verabreichen einer Arznei
EP0956872B1 (fr)	2005-04-06	Appareil de purification du sang
DE69115005T2 (de)	1996-05-15	Verfahren zur Steuerung eines Herzschrittmachers mit einer gesteuerten Reizungsfrequenz.
DE19844252A1 (de)	2000-03-30	Modulare Vorrichtung zur computergesteuerten Insulin- und Glukoseinfusion
DE68918167T3 (de)	2000-02-03	Vorrichtung zur Vorhersage von Nebeneffekten während einer Dialyse.
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